Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

NCT04884607 | Completed DMC

• 1 other identifier: H-2104-191-1214
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

• Purpose of the study This study aimed to investigate electrocardiogram measurement and subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes among healthy adult participants
• Study design Prospective, single-center, interventional, single-arm design
• Study participants A total of 12 healthy adult participants without cardiovascular diseases will be recruited.
• Study methods
• Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital
• Evaluation of electrocardiogram measurement from external auditory canal electrodes Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared.
• Evaluation of low-level autonomic nerve stimulation using external auditory canal Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart.

Conditions

Cardiac Arrhythmia; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  Selected parameters of heart rate variability

  Through study completion, an average of within 1 day

Study Arms (1)

Study group

EXPERIMENTAL

Study group will receive subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes.

Other: subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes

Interventions

subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes OTHER

* Evaluation of electrocardiogram measurement from external auditory canal electrodes: Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared. * Evaluation of low-level autonomic nerve stimulation using external auditory canal: Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart.

Study group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults without cardiovascular diseases
• Aged 20 years or more with Informed consent

You may not qualify if:

• Patients with autonomic disorder, cardiovascular drug prescriptions, cardiovascular diseases, diabetes, or with cardiac implantable electronic devices
• Patients with abnormalities at both external auditory canals and ears

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seil Oh, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 13, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

KR (1)